Olanzapine Teva
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-09-2023
Charakterystyka produktu
(SPC)
25-09-2023
Sprawozdanie z oceny publicznego
(PAR)
01-03-2013
Składnik aktywny:
olanzapine
Dostępny od:
Teva B.V.
Kod ATC:
N05AH03
INN (International Nazwa):
olanzapine
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
2007-12-12
Ulotka dla pacjenta
82
B. PACKAGE LEAFLET
83
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE TEVA 2.5 MG FILM-COATED TABLETS
OLANZAPINE TEVA 5 MG FILM-COATED TABLETS
OLANZAPINE TEVA 7.5 MG FILM-COATED TABLETS
OLANZAPINE TEVA 10 MG FILM-COATED TABLETS
OLANZAPINE TEVA 15 MG FILM-COATED TABLETS
OLANZAPINE TEVA 20 MG FILM-COATED TABLETS
olanzapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Olanzapine Teva is and what it is used for
2.
What you need to know before you take Olanzapine Teva
3.
How to take Olanzapine Teva
4.
Possible side effects
5.
How to store Olanzapine Teva
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE TEVA IS AND WHAT IT IS USED FOR
Olanzapine Teva contains the active substance olanzapine. Olanzapine
Teva belongs to a group of
medicines called antipsychotics and is used to treat the following
conditions:
-
Schizophrenia, a disease with symptoms such as hearing, seeing or
sensing things which are not
there, mistaken beliefs, unusual suspiciousness, and becoming
withdrawn. People with this
disease may also feel depressed, anxious or tense.
-
Moderate to severe manic episodes, a condition with symptoms of
excitement or euphoria.
Olanzapine Teva has been shown to prevent recurrence of these symptoms
in patients with bipolar
disorder whose manic episode has responded to olanzapine treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE TEVA
_ _
DO NOT TAKE OLANZAPINE TEVA
-
if you are allergic to olanzapine or any of the other ingredients of
this medicine (listed in sect
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Teva 2.5 mg film-coated tablets
Olanzapine Teva 5 mg film-coated tablets
Olanzapine Teva 7.5 mg film-coated tablets
Olanzapine Teva 10 mg film-coated tablets
Olanzapine Teva 15 mg film-coated tablets
Olanzapine Teva 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine Teva 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 71.3 mg lactose.
Olanzapine Teva 5 mg film-coated tablets
Each film-coated tablet contains 5 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 68.9 mg lactose.
Olanzapine Teva 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 103.3 mg lactose.
Olanzapine Teva 10 mg film-coated tablets
Each film-coated tablet contains 10 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 137.8 mg lactose.
Olanzapine Teva 15 mg film-coated tablets
Each film-coated tablet contains 15 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 206.7 mg lactose.
Olanzapine Teva 20 mg film-coated tablets
Each film-coated tablet contains 20 mg olanzapine.
_Excipient with known effect _
Each film-coated tablet contains 275.5 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Olanzapine Teva 2.5 mg film-coated tablets
White, biconvex, round film-coated tablets, debossed ”OL 2.5” on
one side and plain on the other.
Olanzapine Teva 5 mg film-coated tablets
White, biconvex, round film-coated tablets, debossed ”OL 5” on one
side and plain on the other.
Olanzapine Teva 7.5 mg film-coated tablets
White, biconvex, round film-coated tablets, debossed ”OL 7.5” on
one side and plain on the other.
3
Olanzapine Teva 10 mg film-coated tablets
White, biconvex, round film-coated tablets, debossed
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